Study to Test the Accuracy and Precision of the CareSens Air 3 Continuous Glucose Monitor in Adults with Type 1 Diabetes

What this Trial Is About

Researchers are evaluating the accuracy and precision of the CareSens Air 3 continuous glucose monitoring CGM system in adults with type 1 diabetes. This open-label, single-arm pilot study focuses on adult patients aged 18 to 65 who use intensive insulin therapy. The study aims to provide detailed data on how well this CGM system measures glucose levels compared to a reference device, helping to understand its performance in real-world use. Participants will wear two CareSens Air 3 devices at different insertion sites and one Libre 3 Plus device for 16 days. During this period, they will not have access to glucose readings from the CareSens Air 3 devices. They will continue their usual diabetes treatment and perform at least eight daily finger-stick blood glucose tests using a self-monitoring blood glucose SMBG system. The study includes four clinic visits for glucose measurements under carefully controlled conditions, including testing during low and high blood sugar levels. Throughout the 16-day study, participants will be monitored through frequent blood tests and controlled glucose assessments in the clinic. Researchers will measure the accuracy and precision of glucose concentration readings from the CareSens Air 3 devices compared to reference glucose levels. This includes tracking participants blood glucose regularly and ensuring safety. The trial will last from the start of device insertion through removal after 16 days, with ongoing observation during clinic visits.

Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM